Phase 1 meCS6 + LT(R192G) Vaccine Study

United States Army Medical Research and Development Command (USAMRDC)

Status and phase

Withdrawn

Phase 1

Conditions

Diarrhea

Treatments

Biological: meCS6 + LT(R192G)

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00090688

WRAIR 1065

HSRRB A-12367

Details and patient eligibility

About

The study will enroll approximately 60 volunteers. The vaccine is given as a drink in flavored soda water. Volunteers will either receive a 3-dose vaccination with doses spaced two weeks apart or a 4-dose vaccination with doses spaced 2 days apart depending upon their availability for follow-up.

Once assigned to a vaccination schedule, volunteers will be randomly assigned to receive the meCS6 vaccine with or without the mLT adjuvant for all vaccine doses. Neither the study investigators nor the volunteers will know which group they are assigned.

Volunteers will be asked to be available for clinic visits and telephone follow-ups during the study period and provide blood and stool specimens for testing.

Full description

The Phase 1 section of this study is a randomized double blind trial in which a total of 60 subjects (minimum of 52 allowable) will receive on of two oral vaccine doses according to the following chart:

Group Subset N CS6(Encapsulated) LT(R192G) I A 15 0.95mg 2 micrograms II B 15 0.95mg -- III A 15 0.95mg 2 micrograms IV B 15 0.95mg --

*minimum of 13 volunteers/group

Volunteers in Group I will receive three immunizations (study days 0, 14, and 28) during the vaccine series. Volunteers in Group II will receive four immunizations (study days 0, 2, 4, and 6) during the vaccine series. The two groups will be vaccinated separately for logistical purposes. Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Vaccine safety will be actively evaluated during vaccination and for 4 weeks following the final vaccine dose.

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Available for required follow-up period
Women must have a negative pregnancy test
Women must not to try to become pregnant while on study and for 2 months after study is completed

Exclusion criteria

History of travellers' diarrhea
Occupation that involves handling of E. coli or cholera bacteria, or E. coli vaccine
Regular use of anti-diarrheal, anti-constipation, or antacid therapy
Abnormal bowel habits
Pregnant or nursing women
History of chronic gastrointestinal illness or major gastrointestinal surgery
Allergies to vaccines
Positive HIV, Hepatitis B or Hepatitis C tests
Regular use of oral steroid medication
Clinically significant abnormalities on physical examination